Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (50 of 2024)

Schedule 1   Amendment of the Therapeutic Goods Act 1989

Part 2   Regulation of vaping goods

Division 1   Main amendments

Therapeutic Goods Act 1989
11   After Chapter 4

Insert:

Chapter 4A - Vaping goods

Part 4A-1 - Introduction

Division 1 - Introduction

41N Simplified outline of this Chapter

The importation into Australia of vaping goods, and the manufacture, supply or possession of vaping goods in Australia, is prohibited, subject to some exceptions. A person may commit an offence or be liable to a civil penalty for contravening the prohibitions (see Part 4A-2).

Definitions of vaping goods and related terms are set out in Division 2 of this Part. Vaping goods includes vaping substances, vaping accessories, vaping devices and goods determined by the Minister to be vaping goods.

The Minister may, by legislative instrument, determine that specified vaping goods, or a specified class of vaping goods, may be supplied or possessed in Australia:

(a) by a specified person, or a specified class of persons; and

(b) in the circumstances (if any) specified in the determination; and

(c) subject to the conditions (if any) specified in the determination (see Part 4A-3).

The Secretary may, on application by a person, give the person consent to manufacture, supply or possess vaping goods. The consent may be given unconditionally or subject to conditions, and in respect of particular vaping goods or classes of vaping goods. In deciding whether to give a consent, the Secretary must comply with the decision-making principles (if any) determined by the Minister by legislative instrument. A person may commit an offence or be liable to a civil penalty if conditions of a consent are breached (see Part 4A-3).

41NA Relationship with other Chapters of this Act

An offence provision or civil penalty provision in this Chapter does not limit the generality of an offence provision or civil penalty provision in any other Chapter, and those provisions in other Chapters do not limit the generality of offence provisions or civil penalty provisions in this Chapter.

Division 2 - Interpretation

41P Meaning of vaping goods and related terms

(1) In this Act:

vaping accessory means a cartridge, capsule, pod or other vessel:

(a) that is for use in, or with, a vaping device; and

(b) whether or not the cartridge, capsule, pod or other vessel:

(i) contains a vaping substance; or

(ii) is designed or intended to be refilled.

vaping device means:

(a) a device (whether or not filled with a vaping substance) that generates or releases, or is designed or intended to generate or release, using a heating element and by electronic means, an aerosol, vapour or mist for direct inhalation by its user; or

(b) a device to which paragraph (a) would apply if the device were not temporarily or permanently inoperable, incomplete, damaged or unfinished.

Note: Examples of devices that are not vaping devices include the following:

(a) humidifiers;

(b) diffusers;

(c) nebulisers;

(d) inhalers.

vaping goods means any of the following goods:

(a) a vaping substance;

(b) a vaping accessory;

(c) a vaping device;

(d) goods the presentation of which includes an express or implied representation that the goods are of a kind referred to in paragraph (a), (b) or (c);

(e) goods that are, or are included in a class of goods that are, determined to be vaping goods under subsection (3).

Note: This definition is affected by subsection (2).

vaping substance :

(a) means:

(i) nicotine in solution in any concentration (including in a salt or base form); or

(ii) any liquid or other substance for use in, or with, a vaping device; and

(b) includes a container (other than a vaping accessory or vaping device), or part of such a container, in which a liquid or other substance referred to in subparagraph (a)(i) or (ii) is present.

(2) For the purposes of paragraph (d) of the definition of vaping goods in subsection (1):

(a) the presentation of goods includes matters in relation to:

(i) the name of the goods; and

(ii) the labelling and packaging of the goods; and

(iii) any advertising or informational material associated with the use or supply of the goods; and

(b) goods are taken to be presented as being a particular kind of goods even if the presentation:

(i) is capable of being misleading or confusing as to the content or proper use or identification of the goods; or

(ii) suggests that the goods have ingredients, components or characteristics that they do not have.

Minister may determine that goods are or are not vaping goods etc.

(3) The Minister may, by legislative instrument, determine that, for the purposes of this Act, specified goods or specified classes of goods:

(a) are or are not vaping goods; or

(b) when used, advertised, or presented for use or supply in a particular way, are or are not vaping goods.

Part 4A-2 - Offences and civil penalty provisions relating to vaping goods

Division 1 - General

41Q Offences and civil penalty provision - importing vaping goods into Australia

Offences

(1) A person commits an offence if the person imports vaping goods into Australia.

Penalty: Imprisonment for 7 years or 5,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence of strict liability if the person imports vaping goods into Australia.

Penalty: 200 penalty units.

Civil penalty provision

(3) A person contravenes this subsection if the person imports vaping goods into Australia.

Maximum civil penalty:

(a) for an individual - 7,000 penalty units; and

(b) for a body corporate - 70,000 penalty units.

(4) A person who contravenes subsection (3) commits a separate contravention of that subsection in respect of each unit of vaping goods imported by the person into Australia.

Note: For unit of vaping goods, see subsection 3(1).

Exception

(5) Subsections (1) to (4) do not apply if the importation of the vaping goods is not prohibited under the Customs Act 1901.

Note: The person bears an evidential burden in relation to the matter in subsection (5): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

41QA Offences and civil penalty provision - manufacturing vaping goods in Australia

Offences

(1) A person commits an offence if the person manufactures, or carries out a step in the manufacture of, vaping goods in Australia.

Penalty: Imprisonment for 7 years or 5,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence of strict liability if the person manufactures, or carries out a step in the manufacture of, vaping goods in Australia.

Penalty: 200 penalty units.

Civil penalty provision

(3) A person contravenes this subsection if the person manufactures, or carries out a step in the manufacture of, vaping goods in Australia.

Maximum civil penalty:

(a) for an individual - 7,000 penalty units; and

(b) for a body corporate - 70,000 penalty units.

(4) A person who contravenes subsection (3) commits a separate contravention of that subsection in respect of the manufacture, or the carrying out of the step in the manufacture, by the person of each unit of vaping goods.

Note: For unit of vaping goods, see subsection 3(1).

Exceptions

(5) Subsections (1) to (4) do not apply if:

(a) the vaping goods are therapeutic goods; and

(b) one of the following subparagraphs applies:

(i) the person is the holder of a licence in force under Part 3-3 that authorises the manufacture of the vaping goods, or the carrying out of the step in the manufacture of the vaping goods, at the manufacturing site where the manufacture, or the step, is carried out;

(ii) the person is the holder of a conformity assessment document that applies to the vaping goods;

(iii) the Secretary has given the person a consent under subsection 41RC(1) to manufacture the vaping goods, or carry out the step in the manufacture of the vaping goods, and the manufacture, or the step, is carried out in accordance with the consent.

Note: The person bears an evidential burden in relation to the matter in subsection (5): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

41QB Offences and civil penalty provision - supplying vaping goods

Offences

(1) A person commits an offence if the person supplies vaping goods in Australia.

Penalty: Imprisonment for 7 years or 5,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence of strict liability if the person supplies vaping goods in Australia.

Penalty: 200 penalty units.

Civil penalty provision

(3) A person contravenes this subsection if the person supplies vaping goods in Australia.

Maximum civil penalty:

(a) for an individual - 7,000 penalty units; and

(b) for a body corporate - 70,000 penalty units.

(4) A person who contravenes subsection (3) commits a separate contravention of that subsection in respect of each unit of vaping goods supplied by the person in Australia.

Note: For unit of vaping goods, see subsection 3(1).

Exceptions - general

(5) Subsections (1) to (4) do not apply if:

(a) subsections (6), (7) and (8) apply in relation to the supply of the vaping goods by the person; or

(b) subsections (9), (10) and (11) apply in relation to the supply of the vaping goods by the person.

Note: The person bears an evidential burden in relation to the matters in subsections (6), (7) and (8) or subsections (9), (10) and (11): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

Exceptions - wholesale supply chain

(6) This subsection applies in relation to the supply of the vaping goods by the person if:

(a) the vaping goods are therapeutic goods that are entered on the Register; or

(b) both of the following apply:

(i) the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of subsection 18(1) or an exempt device under regulations made for the purposes of subsection 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption;

(ii) the vaping goods are not the subject of a determination by the Secretary, published on the Department's website, that the supply of the goods be stopped or should cease because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods; or

(c) the vaping goods are covered by a determination made by the Minister under section 41R.

(7) This subsection applies in relation to the supply of the vaping goods by the person if:

(a) the person:

(i) is the holder of a licence and a permission, granted under regulations made for the purposes of section 50 of the Customs Act 1901, to import the vaping goods; or

(ii) is otherwise approved under those regulations to import the vaping goods; or

(b) the person is the holder of a licence in force under Part 3-3 that authorises a step in the manufacture of the vaping goods; or

(c) the person is the holder of a conformity assessment document that applies to the vaping goods; or

(d) both of the following apply:

(i) the person is a wholesaler who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the supply occurs;

(ii) the supply occurs in accordance with the licence or authority; or

(e) both of the following apply:

(i) the Secretary has given the person a consent under subsection 41RC(1) to supply the vaping goods;

(ii) the supply occurs in accordance with the consent; or

(f) in the case of vaping goods that are covered by a determination made by the Minister under section 41R:

(i) the person is specified in the determination, or is included in a class of persons specified in the determination, in relation to those goods; and

(ii) the supply occurs in accordance with the determination.

(8) This subsection applies in relation to the supply of the vaping goods by the person if:

(a) the person (the recipient ) to whom the vaping goods are supplied is the holder of a licence in force under Part 3-3 of this Act that authorises a step in the manufacture of vaping goods; or

(b) the recipient is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; or

(c) the Secretary has given the recipient a consent under subsection 41RC(1) to supply the vaping goods; or

(d) in the case of vaping goods that are covered by a determination made by the Minister under section 41R - the recipient is specified in the determination, or is included in a class of persons specified in the determination, in relation to those goods.

Exceptions - retail supply chain

(9) This subsection applies in relation to the supply of the vaping goods by the person if:

(a) the vaping goods are therapeutic goods that are entered on the Register; or

(b) both of the following apply:

(i) the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of subsection 18(1) or an exempt device under regulations made for the purposes of subsection 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption;

(ii) the vaping goods are not the subject of a determination by the Secretary, published on the Department's website, that the supply of the goods be stopped or should cease because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods; or

(c) the vaping goods are covered by a determination made by the Minister under section 41R.

(10) This subsection applies in relation to the supply of the vaping goods by the person if:

(a) the person is a pharmacist; or

(b) the person is a medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the supply occurs.

(11) This subsection applies in relation to the supply of the vaping goods by the person if:

(a) the supply is:

(i) to another person for use by that person for smoking cessation, management of nicotine dependence or another indication determined by the Minister under section 41RA; or

(ii) to another person, who is the carer of a third person, for use by the third person for smoking cessation, management of nicotine dependence or another indication determined by the Minister under section 41RA; and

(b) if the vaping goods are, or contain, a vaping substance - the vaping substance is in final dosage form; and

(c) the supply is:

(i) in accordance with this Act (apart from this section); and

(ii) consistent with the person's authority to supply the vaping goods under a law of the State or Territory in which the supply occurs.

Meaning of final dosage form

(12) For the purposes of paragraph (11)(b), a vaping substance is in final dosage form if the vaping substance is in a form that can be administered to a person without any change or modification (other than vaporisation).

41QC Offences and civil penalty provision - possessing at least commercial quantity of vaping goods

Offences - possessing at least commercial quantity but less than 100 times commercial quantity

(1) A person commits an offence if:

(a) the person possesses a quantity of a kind of vaping goods in Australia; and

(b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity, of that kind of vaping goods.

Penalty: Imprisonment for 2 years or 1,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Absolute liability applies to paragraph (1)(b).

(3) A person commits an offence of strict liability if:

(a) the person possesses a quantity of a kind of vaping goods in Australia; and

(b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity, of that kind of vaping goods.

Penalty: 120 penalty units.

Offences - possessing at least 100 times commercial quantity but less than 1,000 times commercial quantity

(4) A person commits an offence if:

(a) the person possesses a quantity of a kind of vaping goods in Australia; and

(b) the quantity is at least 100 times the commercial quantity, but less than 1,000 times the commercial quantity, of that kind of vaping goods.

Penalty: Imprisonment for 4 years or 3,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(5) Absolute liability applies to paragraph (4)(b).

(6) A person commits an offence of strict liability if:

(a) the person possesses a quantity of a kind of vaping goods in Australia; and

(b) the quantity is at least 100 times the commercial quantity, but less than 1,000 times the commercial quantity, of that kind of vaping goods.

Penalty: 240 penalty units.

Offences - possessing 1,000 times commercial quantity or more

(7) A person commits an offence if:

(a) the person possesses a quantity of a kind of vaping goods in Australia; and

(b) the quantity is 1,000 times the commercial quantity, or more, of that kind of vaping goods.

Penalty: Imprisonment for 7 years or 5,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(8) Absolute liability applies to paragraph (7)(b).

(9) A person commits an offence of strict liability if:

(a) the person possesses a quantity of a kind of vaping goods in Australia; and

(b) the quantity is 1,000 times the commercial quantity, or more, of that kind of vaping goods.

Penalty: 420 penalty units.

Civil penalty provision

(10) A person contravenes this subsection if:

(a) the person possesses a quantity of a kind of vaping goods in Australia; and

(b) the quantity is at least the commercial quantity of that kind of vaping goods.

Maximum civil penalty:

(a) for an individual - 7,000 penalty units; and

(b) for a body corporate - 70,000 penalty units.

(11) A person who contravenes subsection (10) in relation to a kind of vaping goods commits a separate contravention of that subsection in respect of each unit of the quantity of vaping goods of that kind possessed by the person in Australia.

Note: For unit of vaping goods, see subsection 3(1).

Exception - possession for personal use

(11A) Subsections (1) to (3) and (10) and (11) do not apply in relation to the possession of a quantity of a kind of vaping goods by the person if:

(a) the vaping goods have been lawfully supplied to the person; and

(b) the vaping goods are for use by the person personally; and

(c) the quantity is less than 5 times the commercial quantity of that kind of vaping goods.

Note: The person bears an evidential burden in relation to the matters in subsection (11A): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

Exceptions - general

(12) Subsections (1) to (11) do not apply if subsections (13) and (14) apply in relation to the possession of the vaping goods by the person.

Note: The person bears an evidential burden in relation to the matters in subsections (13) and (14): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

(13) This subsection applies in relation to the possession of the vaping goods by the person if:

(a) the vaping goods are therapeutic goods that are entered on the Register; or

(b) both of the following apply:

(i) the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of subsection 18(1) or an exempt device under regulations made for the purposes of subsection 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption;

(ii) the vaping goods are not the subject of a determination by the Secretary, published on the Department's website, that the supply of the goods be stopped or should cease because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods; or

(c) the vaping goods are covered by a determination made by the Minister under section 41R.

(14) This subsection applies in relation to the possession of the vaping goods by the person if:

(a) the person:

(i) is the holder of a licence and a permission, granted under regulations made for the purposes of section 50 of the Customs Act 1901, to import the vaping goods; or

(ii) is otherwise approved under those regulations to import the vaping goods; or

(b) the person is the holder of a licence in force under Part 3-3 of this Act that authorises a step in the manufacture of the vaping goods; or

(c) the person is the holder of a conformity assessment document that applies to the vaping goods; or

(d) both of the following apply:

(i) the person is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the person possesses the goods;

(ii) the possession of the goods is in accordance with the licence or authority; or

(e) both of the following apply:

(i) the Secretary has given the person a consent under subsection 41RC(1) to possess the vaping goods;

(ii) the possession is in accordance with the consent; or

(f) in the case of vaping goods that are covered by a determination made by the Minister under section 41R:

(i) the person is specified in the determination, or is included in a class of persons that is specified in the determination, in relation to those goods; and

(ii) the possession is in accordance with the determination.

41QD Offences and civil penalty provision - possessing less than commercial quantity of vaping goods

Offences

(1) A person commits an offence if:

(a) the person is a retailer in relation to retail premises in Australia; and

(b) the person possesses a quantity of a kind of vaping goods at the retail premises; and

(c) the quantity is less than the commercial quantity of that kind of vaping goods.

Penalty: Imprisonment for 12 months or 500 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Absolute liability applies to paragraph (1)(b).

(3) A person commits an offence of strict liability if:

(a) the person is a retailer in relation to retail premises in Australia; and

(b) the person possesses a quantity of a kind of vaping goods at the retail premises; and

(c) the quantity is less than the commercial quantity of that kind of vaping goods.

Penalty: 60 penalty units.

Civil penalty provision

(4) A person contravenes this subsection if:

(a) the person is a retailer in relation to retail premises in Australia; and

(b) the person possesses a quantity of a kind of vaping goods at the retail premises; and

(c) the quantity is less than the commercial quantity of that kind of vaping goods.

Maximum civil penalty:

(a) for an individual - 1,000 penalty units; and

(b) for a body corporate - 10,000 penalty units.

(5) A person who contravenes subsection (4) in relation to a kind of vaping goods commits a separate contravention of that subsection in respect of each unit of the quantity of vaping goods of that kind possessed by the person at the retail premises in Australia.

Note: For unit of vaping goods, see subsection 3(1).

Exceptions - general

(6) Subsections (1) to (5) do not apply if subsections (7) and (8) apply in relation to the possession of the vaping goods by the person.

Note: The person bears an evidential burden in relation to the matters in subsections (7) and (8): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

(7) This subsection applies in relation to the possession of the vaping goods by the person if:

(a) the vaping goods are therapeutic goods that are entered on the Register; or

(b) both of the following apply:

(i) the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of subsection 18(1) or an exempt device under regulations made for the purposes of subsection 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption;

(ii) the vaping goods are not the subject of a determination by the Secretary, published on the Department's website, that the supply of the goods be stopped or should cease because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods; or

(c) the vaping goods are covered by a determination made by the Minister under section 41R.

(8) This subsection applies in relation to the possession of the vaping goods by the person if:

(a) both of the following apply:

(i) the person is a pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the person possesses the goods;

(ii) the possession of the goods is in accordance with the licence or authority; or

(b) both of the following apply:

(i) the Secretary has given the person a consent under subsection 41RC(1) to possess the vaping goods;

(ii) the possession is in accordance with the consent; or

(c) in the case of vaping goods that are covered by a determination made by the Minister under section 41R:

(i) the person is specified in the determination, or is included in a class of persons that is specified in the determination, in relation to those goods; and

(ii) the possession is in accordance with the determination.

Exception - possession for personal use

(9) Subsections (1) to (5) do not apply in relation to the possession of a quantity of a kind of vaping goods by the person if:

(a) the vaping goods are for use by the person personally; and

(b) the quantity is not more than the permitted quantity of that kind of vaping goods.

Note: The person bears an evidential burden in relation to the matters in subsection (9): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

Definitions

(10) In this section:

permitted quantity of a kind of vaping goods means the quantity of that kind of vaping goods prescribed by the regulations.

retailer in relation to retail premises in Australia means any of the following:

(a) an owner, lessee or occupier of retail premises in Australia;

(b) a person conducting a business or undertaking at, or in connection or association with, retail premises in Australia;

(c) a director, officer or agent of a person referred to in paragraph (a) or (b);

(d) a person performing work in any capacity (including, but not limited to, an employee or a contractor) for, or on behalf of, a person referred to in paragraph (a), (b) or (c) at, or in connection or association with, retail premises in Australia.

retail premises means premises:

(a) from which goods or services are available for supply, or are supplied, to a consumer; or

(b) that are used in connection with the supply of goods or services to a consumer;

(whether or not the premises are used wholly or predominantly for that purpose).

Note: For premises , see subsection 3(1).

Division 2 - Miscellaneous

41QE Exceptions etc. to civil penalty provisions - burden of proof

If, in proceedings for a pecuniary penalty order against a person for a contravention of a civil penalty provision in this Chapter, the person wishes to rely on any exception, exemption, excuse, qualification or justification that applies in relation to the civil penalty provision, then the person bears an evidential burden in relation to that matter.

Part 4A-3 - Other provisions

Division 1 - Determinations by Minister

41R Minister may determine that specified vaping goods may be supplied or possessed in Australia in specified circumstances etc.

The Minister may, by legislative instrument, determine that specified vaping goods, or a specified class of vaping goods, may be supplied or possessed in Australia:

(a) by a specified person, or a specified class of persons; and

(b) in the circumstances (if any) specified in the determination; and

(c) subject to the conditions (if any) specified in the determination.

Note: Conditions may, for example, relate to the value or amount of specified vaping goods or the manner in which specified vaping goods may be supplied.

41RA Minister may determine other indications for which vaping goods may be used

The Minister may, by legislative instrument, determine, for the purposes of paragraph 41QB(11)(a), indications (other than smoking cessation or management of nicotine dependence) for which vaping goods may be used.

Division 2 - Consent of Secretary

41RB Application to Secretary for consent to manufacture, supply or possess vaping goods

(1) A person may apply to the Secretary for consent to manufacture, supply or possess vaping goods.

(2) An application under subsection (1) must be in accordance with a form approved by the Secretary.

Further information

(3) The Secretary may, by notice in writing given to the applicant, require the applicant to give to the Secretary, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice.

Applications or information may be given electronically

(4) An approval of a form referred to in subsection (2), or a notice referred to in subsection (3), may require or permit an application or information to be given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

41RC Secretary may give consent

(1) If:

(a) a person (the applicant ) has applied to the Secretary under section 41RB for consent to manufacture, supply or possess vaping goods; and

(b) the applicant has complied with any requirements made by the Secretary under subsection 41RB(3) in relation to the application;

the Secretary must decide whether to give, or refuse to give, the consent.

(2) The Secretary may give a consent under subsection (1):

(a) unconditionally or subject to conditions; or

(b) in respect of particular vaping goods or classes of vaping goods.

Note: A person may commit an offence or be liable to a civil penalty if the person does an act or omits to do an act and the act or omission breaches a condition of a consent given under subsection (1): see section 41RD.

(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B).

(2B) The Minister may, by legislative instrument, determine principles ( decision-making principles ) that the Secretary must comply with in making a decision under subsection (1).

(2C) Without limiting subsection (2B), the decision-making principles may set out any of the following:

(a) circumstances in which a consent under subsection (1) must not be given;

(b) matters that must be taken into account in making a decision under subsection (1);

(c) matters that must not be taken into account in making a decision under subsection (1);

(d) matters that may be taken into account in making a decision under subsection (1).

(3) The Secretary must, as soon as practicable after making a decision to give a consent under subsection (1), cause particulars of the decision to be published on the Department's website.

(4) If the Secretary decides to refuse to give a consent under subsection (1), the Secretary must, within 28 days after making the decision, notify the applicant in writing of the decision and the reasons for the decision.

41RD Offences and civil penalty provision - breaching condition of a consent

Offences

(1) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2); and

(c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2).

Penalty: 500 penalty units.

(3) A person commits an offence of strict liability if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2).

Penalty: 100 penalty units.

Civil penalty provision

(4) A person contravenes this subsection if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2).

Maximum civil penalty:

(a) for an individual - 3,000 penalty units; and

(b) for a body corporate - 30,000 penalty units.